Bionel

Manufacturer
Advanced Generic Corporation
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:47:01

Label at a glance#

ProductBionel Pediatric
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: (in each 5 mL tsp.)              Purpose

Guaifenesin 50 mg .............................................. Expectorant

Dextromethorphan Hydrobromide 5 mg.................. Cough Suppressant

Pseudoephedrine HCl 15 mg.................................. Nasal Decongestant

OTC - PURPOSE SECTION

Uses


  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves these symptoms occurring with a cold: nasal congestion, cough due to minor throat and bronchial irritation.

WARNINGS SECTION

Warnings
Do not usein a child who is taking a prescription
Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression,
psychiatric, or emotional conditions or Parkinson’s disease), or for
2 weeks after stopping the MAOI drug. If you do not know if you are
taking a prescription drug that contains a MAOI; ask a doctor or
pharmacist before taking this product.

OTC - DO NOT USE SECTION

Ask a doctor before use if your child hav

e


  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or occurs with smoking, asthma, chronic bronchitis, or emphysema. A persistent cough may be a sign of a serious condition.

Stop use and ask a doctor if


  • you get nervous, dizzy or sleepless
  • symptoms do not get better within 7 days or accompanied by fever
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions Do not exceed more than 4 doses in any 24-hour period or as directed by a doctor.

Children 6 to under 12 years of age; 45 lbs to under 95 lbs; Take 2 teaspoonfuls (10mL) every 4 to 6 hours

Children 2 to under 6 years of age; 25 lbs to under 45 lbs; Take 1 teaspoonful (5mL) every 4 to 6 hours

Children under 2 years of age; Under 25 lbs; Ask a doctor

INDICATIONS & USAGE SECTION

Other information


  • store at controlled room temperature 20°- 25°C (68° - 77°F); excursion permitted to 15°- 30°C (59°- 86°F) [See USP Controlled Room Temperature]. Tamper evident by imprinted heat seal under cap. Do not use if there is evidence of tampering.

Warning: Phenylketonuric: Contains 14 mg of Phenylalanine per 5 mL (one teaspoonful) dose.

INACTIVE INGREDIENT SECTION

Inactive ingredientsaspartame, citric acid, corn syrup, D and C Red No 33, methylparaben, natural and artificial flavors, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water.

OTC - QUESTIONS SECTION

Questions or comments?1-305-403-3788

Manufactured For:Advanced Generic Corporation, Miami, Fl 33166

www.advancedgeneric.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BionelPedLabelBionelPedLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098911dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN8
1098911dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD8
1098911dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45737-207-162020-12-23C16284748780-19d75b9d0-2ef6-f424-e053-dadaa90a57ceAGC-BionelPed 207
45737-207-162020-01-31C16284748780-19d75b9d0-2ef6-f424-e053-dadaa90a57ceAGC-BionelPed 207

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45737-207-16BionelPediatric473 mL in 1 BOTTLELIQUID4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45737-207BIONEL PEDIATRIC (DEXTROMETHORPHAN, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) LIQUID [ADVANCED GENERIC CORPORATION]8Legacy NDC, 1 package rows20241222_271c5895-25f5-4162-a278-6629b0ad03c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45737-207-16ML - Milliliter45737-207a2b5553c-6c2c-4c95-8fb3-0d7f39345fcf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH5
GuaifenesinACTIVE INGREDIENT495W7451VQ5
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8N5
DextromethorphanACTIVE MOIETY7355X3ROTS5
GuaifenesinACTIVE MOIETY495W7451VQ5
PseudoephedrineACTIVE MOIETY7CUC9DDI9F5
AspartameINACTIVE INGREDIENTZ0H242BBR15
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP5
corn syrupINACTIVE INGREDIENT9G5L16BK6N5
D&C Red No. 33INACTIVE INGREDIENT9DBA0SBB0L5
methylparabenINACTIVE INGREDIENTA2I8C7HI9T5
potassium citrateINACTIVE INGREDIENTEE90ONI6FF5
Potassium SorbateINACTIVE INGREDIENT1VPU26JZZ45
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V35
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH5
WaterINACTIVE INGREDIENT059QF0KO0R5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45737-20745737-207-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 382 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHTABLET, EXTENDED RELEASE / ORAL0.12 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHDROPS / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, FOR SUSPENSION / ORAL420 mgExact identifier — unii candidate
19 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET / ORAL914 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1SUSPENSION / ORAL23 mgExact identifier — unii candidate
19 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
corn syrupCORN SYRUP9G5L16BK6NSUSPENSION, EXTENDED RELEASE / ORAL1500 mg/5mlExact identifier — unii candidate
10 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
potassium citratePOTASSIUM CITRATEEE90ONI6FFSUSPENSION / ORALNAExact identifier — unii candidate
4 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSOLUTION / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
potassium citratePOTASSIUM CITRATEEE90ONI6FFPOWDER, FOR SOLUTION / ORAL570 mgExact identifier — unii candidate
4 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHFILM / BUCCAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PERINEURAL80 mgExact identifier — unii candidate
79 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
68 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1GRANULE, EFFERVESCENT / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION/ DROPS / ORAL19 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
Potassium SorbatePOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
corn syrupCORN SYRUP9G5L16BK6NELIXIR / ORAL400 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
D&C Red No. 33D&C RED NO. 339DBA0SBB0LTABLET, COATED / ORALNAExact identifier — unii candidate
14 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
AspartameASPARTAMEZ0H242BBR1SYRUP / ORAL0.63 mg/5mlExact identifier — unii candidate
19 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TDROPS / AURICULAR (OTIC)0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
29bc44a9-43f2-1d34-e063-6394a90aec4a271c5895-25f5-4162-a278-6629b0ad03c12024-12-20WarningsExact identifier
spl id: 29bc44a9-43f2-1d34-e063-6394a90aec4a
spl set id: 271c5895-25f5-4162-a278-6629b0ad03c1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.